MAUDE Adverse Event Report: ALLERGAN (MEDFORD) SERI SURGICAL SCAFFOLD (US); MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY

Catalog Number SCF15X25AGEN

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Fever (1858); Pain (1994); Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

Medwatch sent to fda on 3/30/2016.The device has not been returned.Therefore, no analysis or testing has been done.These events are being reported because medical intervention was required, although device-relatedness has not been established."fluid discharge" is a physiological complication, and analysis of the device generally does not assist allergan in determining a probable cause for this event.The reporter has declined to provide allergan further information regarding event, product, or patient details.

Event Description

Company representative reported that after implant with seri surgical scaffold, the patient developed blisters, pustules with sterile fluid coming out.Treatment status is unknown.

Manufacturer Narrative

Medwatch sent to fda on 06/16/2016.The events of wound dehiscence, fever, pain, exposure, and inadequate tissue ingrowth are physiological complications, and analysis of the device generally does not assist allergan in determining a probable cause for this event.The physician discarded the device when it was explanted and it is no longer available for return.Therefore allergan will not receive it and no analysis or testing will be done.

Event Description

Physician reported bilateral revision to breast augmentation with seri surgical scaffold on (b)(6) 2015.On (b)(6) 2016, the patient presented with "soreness and open area to breast where implant incision is," and fever.On (b)(6) 2016 physician noted a blister at the left inframammary scar which opened and drained, and two blisters on the right side inframammary crease.The blisters on the right were drained at that time.Physician prescribed silvadene and levaquin.These blisters remained open wounds and continued to drain.On (b)(6) 2016, physician noted exposed seri on the left breast, and decided to continue silvadene applications.The wounds on the left and right continued to grow and more seri became exposed on the left breast.The seri and breast implants were removed on (b)(6) 2016 and the symptoms resolved.Physician reported the device showed zero integration with the patient's tissue, and was completely removed and discarded.

• Brand Name: SERI SURGICAL SCAFFOLD (US)
• Type of Device: MESH, SURGICAL, ABSORBABLE, PLASTIC AND RECONSTRUCTIVE SURGERY
• Manufacturer (Section D): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer (Section G): ALLERGAN (MEDFORD); 200 boston avenue; medford MA 02155
• Manufacturer Contact: suzanne wojcik ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 5536836
• MDR Text Key: 41512247
• Report Number: 8020862-2016-00025
• Device Sequence Number: 1
• Product Code: OXF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123128
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: SCF15X25AGEN
• Device Lot Number: P14073101A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention